NCT01308229

Safety and Efficacy Study of the Nile PAX Drug-Eluting Coronary Bifurcation Stent

Assessment of the Safety and Efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the Treatment of Single de Novo Bifurcation Lesions in Native Coronary Arteries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: MINVASYS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to assess the safety and efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the treatment of single de novo bifurcation lesions in native coronary arteries with a main branch reference vessel diameter of 2.5-3.5 mm and side branch reference vessel diameter of 2.0-3.0 mm.

Detailed description

The BIPAX clinical trial is a prospective, non-randomized, multicenter, clinical trial evaluating the investigational coronary bifurcation device Nile PAX® in patients with main branch reference vessel diameters \>= 2.5 mm and \<= 3.5 mm, side branch reference vessel diameters \>= 2.0 and \<= 3.0 and lesion length \<= 14 mm. The trial allows the treatment of a single de novo bifurcation lesion in native coronary arteries following the provisional T-stenting technique with mandatory pre-dilatation of the main branch. In case the side branch requires a stent the treatment will be completed when possible with a Delta PAX® Drug Eluting Side Branch Stent. The BIPAX clinical trial will enroll 100 patients. All patients will receive Quantitative Coronary Angiography (QCA) after stent implantation and at 9 months follow-up. All patients will have a clinical follow-up at 1, 6, 9 and 12 months and subsequently every year up to 5 years.

Conditions

• Coronary Disease

Interventions

Type	Name	Description
DEVICE	Nile PAX® paclitaxel-eluting coronary stent	Implantation of a Nile PAX bifurcation dedicated drug-eluting stent in coronary arteries to treat stenosis lesions

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-01-01
• Completion: 2015-03-01
• First posted: 2011-03-04
• Last updated: 2015-04-08

Locations

10 sites across 7 countries: Brazil, Bulgaria, France, Italy, Netherlands, Poland, Spain